A Study to Evaluate the Potential Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir When Given With Raltegravir in Healthy Adult Volunteers

Hoffmann-La Roche0 sites20 target enrollmentJanuary 2012

ConditionsHealthy Volunteer

Interventionsraltegravir danoprevir ritonavir

Drugsdanoprevir raltegravir ritonavir

Overview

Phase: Phase 1
Intervention: raltegravir
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Enrollment: 20
Primary Endpoint: Effect of steady-state ritonavir-boosted danoprevir on steady-state raltegravir pharmacokinetics: Area under the concentration-time curve (AUC)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This open-label, multiple dose, single sequence crossover study will evaluate the drug-drug interaction between danoprevir/low-dose ritonavir and raltegravir in healthy volunteers. Subjects will receive raltegravir on Days 1-4 and, after a washout period of 3 days, danoprevir and low-dose ritonavir on Days 8-21, in combination with raltegravir on Days 18-21.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

March 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy non-smoking male and female adults, 18 - 55 years of age, inclusive
•Healthy status defined by absence of evidence of any active or chronic disease
•Medical history without major, recent, or ongoing pathology
•Weight \>/= 50.0 kg
•Body mass index (BMI) 18.0 - 32-0 kg/m2
•Willingness to abstain from alcohol, xanthine-containing beverages or food (e.g. coffee, tea, cola, chocolate, "energy drinks") from 48 hours prior to entry in the clinical site until discharge
•Females of child-bearing potential and males and their female partners of child-bearing potential must agree to use 2 forms of contraception, one of which must be a barrier method, during the study and for 90 days after the last drug administration. Acceptable barrier forms of contraception are condom and diaphragm; acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device (IUD) and/or spermicide

Exclusion Criteria

•Pregnant or lactating females or males with female partners who are pregnant or lactating
•Any history of clinically significant cardiovascular or cerebrovascular disease, hypertension, and/or infections
•Positive test for drugs of abuse at screening or prior to admission to the clinical site during any study period
•Positive for hepatitis B, hepatitis C or HIV infection
•Current smokers or subjects who have discontinued smoking less than 6 months prior to first dose of study medication
•Use of hormonal contraceptives within 30 days before the first dose of study medication
•History of clinically significant drug-related allergy (such as anaphylaxis) or hepatotoxicity

Arms & Interventions

Period 1 Control

Intervention: raltegravir

Period 2 danoprevir/ritonavir

Intervention: danoprevir

Period 2 danoprevir/ritonavir

Intervention: raltegravir

Period 2 danoprevir/ritonavir

Intervention: ritonavir

Outcomes

Primary Outcomes

Effect of steady-state ritonavir-boosted danoprevir on steady-state raltegravir pharmacokinetics: Area under the concentration-time curve (AUC)

Time Frame: approximately 2 months

Secondary Outcomes

Effect of steady-state raltegravir on danoprevir/ritonavir pharmacokinetics: Area under the concentration-time curve (AUC)(Pre-dose Days 8. 14, 15, 16 and 20, pre-and up to 24 h post-dose Days 17 and 21)
Safety: Incidence of adverse events(approximately 2 months)